The following data is part of a premarket notification filed by Biosystems with the FDA for Laboratory Sharps Barrel.
Device ID | K950899 |
510k Number | K950899 |
Device Name: | LABORATORY SHARPS BARREL |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale, NY 11735 |
Contact | Jane E Rubinstein |
Correspondent | Jane E Rubinstein BIOSYSTEMS 210 SHERWOOD AVE. Farmingdale, NY 11735 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-02-27 |
Decision Date | 1995-06-29 |